Actively Recruiting

Age: 45Years - 90Years
All Genders
NCT05549713

The Effect of Upper Blepharoplasty on Vision Quality in the Early Postoperative Period

Led by Osijek University Hospital · Updated on 2024-12-31

40

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Contrast sensitivity (CS) and tear film (TF) changes are noted in late postoperative period after upper blepharoplasty (UB), while the same was rarely investigated in the early postoperative period. The reason for aforementioned improvement of vision quality is unclear. Suggested explanations include changes in higher-order aberrations, elimination of the overlay effect created by excess skin on the upper eyelids and/or eyelashes directed toward the eyelid, or changes in corneal topography (CT) and keratometry. Furthermore, there is no consensus on the best technique for UB. Due not only to different surgical techniques, but also to different methods of measuring the tear film quality, it is very difficult to quantify the aforementioned studies. While changes in tear volume parameters and changes in tear film (TF) rupture have been investigated in detail, changes in the lipid layer have rarely been investigated. According to previous studies, there are different findings about changes in CT after UB. The aim of the research is to determine whether there are anatomical (CT) and functional (TF and CS) changes in subjects with functional dermatochalasis before the procedure and in a month-long postoperative period. The research is conducted on examinees diagnosed by clinical examination with functional dermatochalasis with the exclusion of examinees with ocular or systemic conditions affecting TF, best corrected visual acuity or CT. Detailed medical history and ophthalmologic examination will be performed with grading of the external appearance of the upper eyelids. All diseases and conditions that can lead to changes in CS, TF or corneal defects will be noted. Preoperatively all subjects will have CS recorded in photopic conditions, TF analysis and CT (Keratograph 5M, OCULUS Optikgeraete GmbH, Wetzlar, Germany). UB will be performed in the operating room at the UED. At first (seven days postoperatively) and second (one month postoperative) check-up a CS check will be performed at the UED and TF analysis and CT at Lens LTD.

CONDITIONS

Official Title

The Effect of Upper Blepharoplasty on Vision Quality in the Early Postoperative Period

Who Can Participate

Age: 45Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with functional dermatochalasis on the upper eyelid causing visual field obstruction
  • Swelling of the eyelids in the morning with difficulty opening the eyes
  • Use of forehead muscles to improve upper visual field for daily functioning
  • Experiencing headaches related to eyelid condition
Not Eligible

You will not qualify if you...

  • History of corneal refractive surgery
  • Pterygium or glaucoma
  • Nuclear sclerosis greater than 4th degree
  • Severe dry eye
  • Age-related macular degeneration
  • Neuro-ophthalmological diseases
  • Use of hormone therapy
  • Diabetic retinopathy or prior panretinal photocoagulation
  • Corneal diseases such as keratoconus
  • Eyelid malpositions like entropion, ectropion, or marked eyelid laxity

AI-Screening

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Trial Site Locations

Total: 1 location

1

Osijek University Hospital

Osijek, Croatia, 31000

Actively Recruiting

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Research Team

D

Dunja Bajtl

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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